FDA EIR - ThermoFisher Scientific - March 15, 2017

An FDA inspection of ThermoFisher Scientific's Basingstoke, United Kingdom facility occurred from March 13-15, 2017. This was a routine Quality System Inspection Technique (QSIT) directed by the Center for Devices and Radiological Health (CDRH), focusing on their manufacture of Class II Antibiotic Susceptibility Test (AST) discs and Class I dehydrated culture media. The inspection was conducted under Compliance Program 7382.845 for Medical Device Manufacturers and covered areas such as Corrective and Preventive Actions (CAPA), Management Controls, and Production and Process controls, including equipment validation. Significantly, the inspection found no objectionable conditions, and no FDA-483 (Inspectional Observations) was issued to the firm. Although the inspection reviewed two Class II recalls from 2016 concerning IVD Nitrocefin vials and Gentamicin AST discs, these issues had already been investigated and closed by the FDA prior to this visit. Consequently, no new regulatory actions were required as a direct outcome of this 2017 inspection, indicating the facility was operating in compliance at the time.